him to make a study using synthetic THC. He and colleagues made such a
study. They concluded that synthetic THC effected a significant
reduction in spasticity among multiple sclerosis patients, but study
participants who had also smoked marijuana reported consistently that
marijuana was more effective.
46. Dr. Petro accepts marijuana as having a medical use in the
treatment of spasticity in the United States. If it were legally
available and he was engaged in an active medical practice again, he
would not hesitate to prescribe marijuana, when appropriate, to patients
afflicted with uncontrollable spasticity.
47. Dr. Petro presented a paper to a meeting of the American
Academy of Neurology. The paper was accepted for presentation. After he
presented it Dr. Petro found that many of the neurologists present at
this most prestigious meeting were in agreement with his acceptance of
marijuana as having a medical use in the treatment of spasticity.
48. Dr. Andrew Weil, a general medicine practitioner in Tucson,
Arizona, who also teaches at the University of Arizona College of
Medicine, accepts marijuana as having a medical use in the treatment of
spasticity. In multiple sclerosis patients the muscles become tense and
rigid because their nerve supply is interrupted. Marijuana relieves this
spasticity in many patients, he has found. He would prescribe it to
selected patients if it were legally available,
49. Dr. Lester B. Collins, III, a neurologist, then treating
about 20 multiple sclerosis patients a year, seeing two or three new ones
each year, stated in 1983 that he had no doubt that marijuana worked
symptomatically for some multiple sclerosis patients. He said that it
does not alter the course of
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the disease but it does relieve the symptoms of spasticity.
50. Dr. John P. Morgan, board certified in internal medicine,
Professor of Medicine and Director of Pharmacology at CCNY Medical School
in New York and Associate Professor of Medicine and Pharmacology at Mt.
Sinai School of Medicine, accepts marijuana as having medical use in
treatment in the United States. If he were practicing medicine and
marijuana were legally available he would prescribe it when indicated to
patients with legitimate medical needs.
Discussion
Based upon the rationale set out in pages 26 to 34, above, the
administrative law judge concludes that, within the meaning of the Act,
21 U.S.C. § 812(b)(2)(B), marijuana "has a currently accepted medical use
in treatment in the United States" for spasticity resulting from multiple
sclerosis and other causes. It would be unreasonable, arbitrary and
capricious to find otherwise. The facts set out above, uncontroverted by
the Agency, establish beyond question that some doctors in the United
States accept marijuana as helpful in such treatment for some patients.
The record here shows that they constitute a significant minority of
physicians. Nothing more can reasonably be required. That some doctors
would have more studies and test results in hand before accepting
marijuana's usefulness here is irrelevant.
The same is true with respect to the hyperparathyroidism from which
Irvin Rosenfeld suffers. His disease is so rare, and so few physicians
appear to be familiar with it, that acceptance by one doctor of marijuana
as being useful in treating it ought to satisfy the requirement for a
significant minority. The Agency points to no evidence of record tending
to establish that marijuana is
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not accepted by doctors in connection with this most unusual ailment.
Refusal to acknowledge acceptance by a significant minority, in light of
the case history detailed in this record, would be unreasonable,
arbitrary and capricious.
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VIII.
ACCEPTED SAFETY FOR USE UNDER MEDICAL SUPERVISION
With respect to whether or not there is "a lack of accepted safety
for use of [marijuana] under medical supervision", the record shows the
following facts to be uncontroverted.
Findings of Fact
1. Richard J. Gralla, M.D., an oncologist and Professor of
Medicine who was an Agency witness, accepts that in treating cancer
patients oncologists can use the cannabinoids with safety despite their
side effects.
2. Andrew T. Weil, M.D., who now practices medicine in Tucson,
Arizona and is on the faculty of the College of Medicine, University of
Arizona, was a member of the first team of researchers to perform a
Federal Government authorized study into the effects of marijuana on
human subjects. This team made its study in 1968. These researchers
determined that marijuana could be safely used under medical supervision.
In the 20 years since then Dr. Weil has seen no information that would
cause him to reconsider that conclusion. There is no question in his
mind but that marijuana is safe for use under appropriate medical
supervision.
3. The most obvious concern when dealing with drug safety is
the possibility of lethal effects. Can the drug cause death?
4. Nearly all medicines have toxic, potentially lethal
effects. But marijuana is not such a substance. There is no record in
the extensive medical literature describing a proven, documented
cannabis-induced fatality.
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5. This is a remarkable statement. First, the record on
marijuana encompasses 5,000 years of human experience. Second, marijuana
is now used daily by enormous numbers of people throughout the world.
Estimates suggest that from twenty million to fifty million Americans
routinely, albeit illegally, smoke marijuana without the benefit of
direct medical supervision. Yet, despite this long history of use and
the extraordinarily high numbers of social smokers, there are simply no
credible medical reports to suggest that consuming marijuana has caused a
single death.
6. By contrast aspirin, a commonly used, over-the-counter
medicine, causes hundreds of deaths each year.
7. Drugs used in medicine are routinely given what is called
an LD-50. The LD-50 rating indicates at what dosage fifty percent of
test animals receiving a drug will die as a result of drug induced
toxicity. A number of researchers have attempted to determine
marijuana's LD-50 rating in test animals, without success. Simply
stated, researchers have been unable to give animals enough marijuana to
induce death.
8. At present it is estimated that marijuana's LD-50 is around
1:20,000 or 1:40,000. In layman terms this means that in order to induce
death a marijuana smoker would have to consume 20,000 to 40,000 times as
much marijuana as is contained in one marijuana cigarette. NIDA-supplied
marijuana cigarettes weigh approximately .9 grams. A smoker would
theoretically have to consume nearly 1,500 pounds of marijuana within
about fifteen minutes to induce a lethal response.
9. In practical terms, marijuana cannot induce a lethal
response as a result of drug-related toxicity.
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10. Another common medical way to determine drug safety is
called the therapeutic ratio. This ratio defines the difference between
a therapeutically effective dose and a dose which is capable of inducing
adverse effects.
11. A commonly used over-the-counter product like aspirin has a
therapeutic ratio of around 1:20. Two aspirins are the recommended dose
for adult patients. Twenty times this dose, forty aspirins, may cause a
lethal reaction in some patients, and will almost certainly cause gross
injury to the digestive system, including extensive internal bleeding.
12. The therapeutic ratio for prescribed drugs is commonly
around 1:10 or lower. Valium, a commonly used prescriptive drug, may
cause very serious biological damage if patients use ten times the
recommended (therapeutic) dose.
13. There are, of course, prescriptive drugs which have much
lower therapeutic ratios. Many of the drugs used to treat patients with
cancer, glaucoma and multiple sclerosis are highly toxic. The
therapeutic ratio of some of the drugs used in antineoplastic therapies,
for example, are regarded as extremely toxic poisons with therapeutic
ratios that may fall below 1:1.5. These drugs also have very low LD-50
ratios and can result in toxic, even lethal reactions, while being
properly employed.
14. By contrast, marijuana's therapeutic ratio, like its LD-50,
is impossible to quantify because it is so high.
15. In strict medical terms marijuana is far safer than many
foods we commonly consume. For example, eating ten raw potatoes can
result in a toxic response. By comparison, it is physically impossible
to eat enough marijuana to induce death.
16. Marijuana, in its natural form, is one of the safest
therapeutically
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active substances known to man. By any measure of rational analysis
marijuana can be safely used within a supervised routine of medical care.
17. Some of the drugs most widely used in chemotherapy
treatment of cancer have adverse effects as follows:
Cisplatin, one of the most powerful chemo-
therapeutic agents used on humans - may cause deafness;
may lead to life-threatening kidney difficulties and
kidney failure; adversely affects the body's immune
system, suppressing the patient's ability to fight a
host of common infections.
Nitrogen Mustard, a drug used in therapy for
Hodgkins disease - nauseates; so toxic to the skin
that, if dropped on the skin, this chemical literally
eats it away along with other tissues it contacts; if
patient's intravenous lead slips during treatment and
this drug gets on or under the skin the patient may
suffer serious injury including temporary, and in
extreme cases, permanent, loss of use of the arm.
Procarbizine, also used for Hodgkins disease -
has known psychogenic, i.e., emotional, effects.
Cyoxin, also known as Cyclophosphanide -
suppresses patient's immune system response; results
in serious bone marrow depletion; studies indicate
this drug may also cause other cancers, including
cancers of the bladder.
Adriamycan, has numerous adverse effects; is
difficult to employ in long term therapies because it
destroys the heart muscle.
While each of these agents has its particular adverse effects, as
indicated above, they also cause a number of similar, disturbing adverse
effects. Most of these drugs cause hair loss. Studies increasingly
indicate all of these drugs may cause other forms of cancer. Death due
to kidney, heart or respiratory failure is a very real possibility with
all of these agents and the margin for error is minimal. Similarly,
there is a danger of overdosing a patient weakened by his cancer. Put
simply, there is very great risk associated with the medical
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use of these chemicals agents. Despite these high risks, all of these
drugs are considered "safe" for use under medical supervision and are
regularly administered to patients on doctor's orders in the United
States today.
18. There have been occasional instances of panic reaction in
patients who have smoked marijuana. These have occurred in marijuana-
naive persons, usually older persons, who are extremely anxious over the
forthcoming chemotherapy and troubled over the illegality of their having
obtained the marijuana. Such persons have responded to simple person-to-
person communication with a doctor and have sustained no long term mental
or physical damage. If marijuana could be legally obtained, and
administered in an open, medically-supervised session rather than
surreptitiously, the few instances of such adverse reaction doubtless
would be reduced in number and severity.
19. Other reported side effects of marijuana have been minimal.
Sedation often results. Sometimes mild euphoria is experienced. Short
periods of increased pulse rate and of dizziness are occasionally
experienced. Marijuana should not be used by persons anxious or
depressed or psychotic or with certain other health problems. Physicians
could readily screen out such patients if marijuana were being employed
as an agent under medical supervision.
20. All drugs have "side effects" and all drugs used in
medicine for their therapeutic benefits have unwanted, unintended,
sometimes adverse effects.
21. In medical treatment "safety" is a relative term. A drug
deemed "safe" for use in treating a life-threatening disease might be
"unsafe" if prescribed for a patient with a minor ailment. The concept
of drug "safety" is relative. Safety is measured against the
consequences a patient would confront in the absence of therapy. The
determination of "safety" is made in terms of
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whether a drug's benefits outweigh its potential risks and the risks of
permitting the disease to progress.
22. In the context of glaucoma therapy, it must be kept in mind
that glaucoma, untreated, progressively destroys the optic nerve and
results in eventual blindness. The danger, then, to patients with
glaucoma is an irretrievable loss of their sight.
23. Glaucoma is not a mortal disease, but a highly specific,
selectively incapacitating condition. Glaucoma assaults and destroys the
patient's most evolved and critical sensory ability, his or her vision.
The vast majority of patients afflicted with glaucoma are adults over the
age of thirty. The onset of blindness in middle age or later throws
patients into a wholly alien world. They can no longer do the work they
once did. They are unable to read a newspaper, drive a car, shop, walk
freely and do all the myriad things sighted people take for granted.
Without lengthy periods of retraining, adaptation and great effort these
individuals often lose their sense of identity and ability to function.
Those who are young enough or strong-willed enough will regain a sense of
place, hold meaningful jobs, but many aspects of the life they once took
for granted cannot be recaptured. Other patients may never fully adjust
to their new, uncertain circumstances.
24. Blindness is a very grave consequence. Protecting patients
from blindness is considered so important that, for ophthalmologists
generally, it justifies the use of toxic medicines and uncertain surgical
procedures which in other contexts might be considered "unsafe." In
practice, physicians often provide glaucoma patients with drugs which
have many serious adverse effects.
25. There are only a limited number of drugs available for the
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treatment of glaucoma. All of these drugs produce adverse effects.
While several government witnesses lightly touched on the side effects of
these drugs, none provided a full or detailed description of their known
adverse consequences.
26. The adverse physical consequences resulting from the
chronic use of commonly employed glaucoma control drugs include a vast
range of unintended complications from mild problems like drug induced
fevers, skin rashes, headaches, anorexia, asthma, pulmonary difficulties,
hypertension, hypotension and muscle cramps to truly serious, even life-
threatening complications including the formation of cataracts, stomach
and intestinal ulcers, acute respiratory distress, increases and
decreases in heart rate and pulse, disruption of heart function, chronic
and acute renal disease, and bone marrow depletion.
27. Finally, each FDA-approved drug family used in glaucoma
therapy is capable of producing a lethal response, even when properly
prescribed and used. Epinephrine can lead to elevated blood pressure
which may result in stroke or heart attack. Miotic drugs suppress
respiration and can cause respiratory Paralysis. Diuretic drugs so alter
basic body chemistry they cause renal stones and may destroy the
patient's kidneys or result in death due to heart failure. Timolol and
related beta-blocking agents, the most recently approved family of
glaucoma control drugs, can trigger severe asthma attacks or cause death
due to sudden cardiac arrhythmias often producing cardiac arrest.
28. Both of the FDA-approved drugs used in treating the
symptoms of multiple sclerosis, Dantrium and Lioresal, while accepted as
"safe" can, in fact, be very dangerous substances. Dantrium or
dantrolene sodium carries a boxed warning in the Physician's Desk
Reference (PDR) because of its very high toxicity. Patients using this
drug run a very real risk of developing sympto-
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matic hepatitis (fatal and nonfatal). The list of sublethal toxic
reactions also underscores just how dangerous Dantrium can be. The PDR,
in part, notes Dantrium commonly causes weakness, general malaise and
fatigue and goes on to note the drug can also cause constipation, GI
bleeding, anorexia, gastric irritation, abdominal cramps, speech
disturbances, seizure, visual disturbances, diplopia, tachycardia,
erratic blood pressure, mental confusion, clinical depression, renal
disturbances, myalgia, feelings of suffocation and death due to liver
failure.
29. The adverse effects associated with Lioresal baclofen are
somewhat less severe, but include possibly lethal consequences, even when
the drug is properly prescribed and taken as directed. The range on
sublethal toxic reactions is similar to those found with Dantrium.
30. Norman E, Zinberg, M.D., one of Dr. Weil's colleagues in
the 1968 study mentioned in finding 2, above, accepts marijuana as being
safe for use under medical supervision. If it were available by
prescription he would use it for appropriate patients.
31. Lester Grinspoon, M.D., practicing psychiatrist researcher
and Associate Professor of Medicine at Harvard Medical School, accepts
marijuana as safe for use under medical supervision. He believes its
safety is its greatest advantage as a medicine in appropriate cases.
32. Tod H. Mikuriya, M.D., a psychiatrist practicing in
Berkley, California who treats substance abusers as inpatients and
outpatients, accepts marijuana as safe for use under medical supervision.
33. Richard D. North, M.D., who has treated Robert Randall for
glaucoma with marijuana for nine years, accepts marijuana as safe for use
by his patient
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under medical supervision. Mr. Randall has smoked ten marijuana
cigarettes a day during that period without any evidence of adverse
mental or physical effects from it.
34. John C. Merritt, M.D., an expert in ophthalmology, who has
treated Robert Randall and others with marijuana for glaucoma, accepts
marijuana as being safe for use in such treatment.
35. Deborah B. Goldberg, M.D., formerly a researcher in
oncology and now a practicing physician, having worked with many cancer
patients, observed them, and heard many tell of smoking marijuana
successfully to control emesis, accepts marijuana is proven to be an
extremely safe anti-emetic agent. When compared with the other, highly
toxic chemical substances routinely prescribed to cancer patients, Dr.
Goldberg accepts marijuana as clearly safe for use under medical
supervision. (See finding 17, above.)
36. Ivan Silverberg, M.D., board certified in oncology and
practicing that specialty in the San Francisco area, has accepted
marijuana as a safe anti-emetic when used under medical supervision.
Although illegal, it is commonly used by patients in the San Francisco
area with the knowledge and acquiescence of their doctors who readily
accept it as being safe for such use.
37. It can be inferred that all of the doctors and other health
care professionals referred to in the findings in Sections V, VI and VII,
above, who tolerate or permit patients to self-administer illegal
marijuana for therapeutic benefit, accept the substance as safe for use
under medical supervision.
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Discussion
The Act, at 21 U.S.C. § 812(b)(1)(C), requires that marijuana be
retained in Schedule I if "[t]here is a lack of accepted safety for use
of [it] under medical supervision." If there is no lack of such safety,
if it is accepted that this substance can be used with safety under
medical supervision, then it is unreasonable to keep it in Schedule I.
Again we must ask - "accepted" by whom? In the MDMA proceeding the
Agency's first Final Rule decided that "accepted" here meant, as in the
phrase "accepted medical use in treatment", that the FDA had accepted the
substance pursuant to the provisions of the Food, Drug and Cosmetic Act.
51 Fed. Reg. 36555 (1986). The Court of Appeals held that this was
error. On remand, in its third Final Rule on MDMA, the Agency made the
same ruling as before, relying essentially on the same findings, and on
others of similar nature, just as it did with respect to "accepted
medical use." 53 Fed. Reg. 5156 (1988).
The administrative law judge finds himself constrained not to follow
the rationale in that MDMA third Final Order for the same reasons as set
out above in Section V with respect to "accepted medical use" in
oncology. See pages 30 to 33. Briefly, the Agency was looking primarily
at the results of scientific tests and studies rather than at what
physicians had, in fact, accepted. The Agency was wrongly basing its
decision on a judgment as to whether or not doctors ought to have
accepted the substance in question as safe for use under medical
supervision. The criteria the Agency applied in the MDMA third Final
Rule are inappropriate. The only proper question for the Agency here is:
Have a significant minority of physicians accepted marijuana as safe for
use under medical supervision?
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The gist of the Agency's case against recognizing marijuana's
acceptance as safe is to assert that more studies, more tests are needed.
The Agency has presented highly qualified and respected experts,
researchers and others, who hold that view. But, as demonstrated in the
discussion in Section V above, it is unrealistic and unreasonable to
require unanimity of opinion on the question confronting us. For the
reasons there indicated, acceptance by a significant minority of doctors
is all that can reasonably be required. This record makes it abundantly
clear that such acceptance exists in the United States.
Findings are made above with respect to the safety of medically
supervised use of marijuana by glaucoma patients. Those findings are
relevant to the safety issue even though the administrative law judge
does not find accepted use in treatment of glaucoma to have been shown.
Based upon the facts established in this record and set out above
one must reasonably conclude that there is accepted safety for use of
marijuana under medical supervision. To conclude otherwise, on this
record, would be unreasonable, arbitrary and capricious.
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IX.
CONCLUSION
AND
RECOMMENDED DECISION
Based upon the foregoing facts and reasoning, the administrative law
judge concludes that the provisions of the Act permit and require the
transfer of marijuana from Schedule I to Schedule II. The Judge realizes
that strong emotions are aroused on both sides of any discussion
concerning the use of marijuana. Nonetheless it is essential for this
Agency, and its Administrator, calmly and dispassionately to review the
evidence of record, correctly apply the law, and act accordingly.
Marijuana can be harmful. Marijuana is abused. But the same is
true of dozens of drugs or substances which are listed in Schedule II so
that they can be employed in treatment by physicians in proper cases,
despite their abuse potential.
Transferring marijuana from Schedule I to Schedule II will not, of
course, make it immediately available in pharmacies throughout the
country for legitimate use in treatment. Other government authorities,
Federal and State, will doubtless have to act before that might occur.
But this Agency is not charged with responsibility, or given authority,
over the myriad other regulatory decisions that may be required before
marijuana can actually be legally available. This Agency is charged
merely with determining the placement of marijuana pursuant to the
provisions of the Act. Under our system of laws the responsibilities of
other regulatory bodies are the concerns of those bodies, not of this
Agency,
There are those who, in all sincerity, argue that the transfer of
marijuana
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to Schedule II will "send a signal" that marijuana is "OK" generally for
recreational use. This argument is specious. It presents no valid
reason for refraining from taking an action required by law in light of
the evidence. If marijuana should be placed in Schedule II, in obedience
to the law, then that is where marijuana should be placed, regardless of
misinterpretation of the placement by some. The reasons for the
placement can, and should, be clearly explained at the time the action is
taken. The fear of sending such a signal cannot be permitted to override
the legitimate need, amply demonstrated in this record, of countless
suffers for the relief marijuana can provide when prescribed by a
physician in a legitimate case.
The evidence in this record clearly shows that marijuana has been
accepted as capable of relieving the distress of great numbers of very
ill people, and doing so with safety under medical supervision. It would
be unreasonable, arbitrary and capricious for DEA to continue to stand
between those sufferers and the benefits of this substance in light of
the evidence in this record.
The administrative law judge recommends that the Administrator
conclude that the marijuana plant considered as a whole has a currently
accepted medical use in treatment in the United States, that there is no
lack of accepted safety for use of it under medical supervision and that
it may lawfully be transferred from Schedule I to Schedule II. The judge
recommends that the Administrator transfer marijuana from Schedule I to
Schedule II.
Dated: SEP 6 1988
Francis L. Young
Administrative Law Judge
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